Job Title: Safety & Pharmacovigilance Specialist I – QC Experience
Location: Madhapur, Telangana, India
Employment Type: Full-Time
Experience Required: 3+ years in Pharmacovigilance Case Processing with QC experience
Job ID: 25104167
Updated: January 8, 2026
Syneos Health®, a global leader in biopharmaceutical solutions, is seeking a Safety & Pharmacovigilance (PV) Specialist I with Quality Control (QC) experience to join our Pharmacovigilance team. This role focuses on ensuring accurate case processing, regulatory compliance, and high-quality safety reporting across clinical trials and post-marketing programs.
As a PV Specialist I, you will contribute to the review, validation, and QC of Individual Case Safety Reports (ICSRs), ensuring adherence to global GVP, ICH, and GCP standards, while supporting continuous improvement initiatives within the pharmacovigilance function.
Process and QC ICSRS in PVG and safety tracking systems, ensuring completeness, accuracy, and regulatory reportability.
Code events, medical history, concomitant medications, and laboratory tests using MedDRA and maintain drug dictionaries.
Compile complete narrative summaries and perform follow-ups on queries to ensure data integrity.
Manage duplicate ICSRs, SPOR/IDMP activities, and xEVMPD product record submissions.
Perform literature screening and review to identify safety signals or case-relevant data.
Support quality review of ICSRs and ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with SOPs, Work Instructions (WIs), global regulations, and project-specific safety plans.
Participate in internal and external audits as required.
Foster professional collaboration with internal teams, project members, and external stakeholders.
Contribute to trend analysis, risk management assessments, and safety reporting processes.
Bachelor’s degree in Life Sciences, Pharmacy, or equivalent; registered nurse qualifications acceptable.
Minimum 3 years of experience in pharmacovigilance case processing, including QC of ICSRs.
Experience with clinical trial, post-marketing surveillance (PMS), and spontaneous cases.
Proficiency in safety databases and medical terminology.
Strong knowledge of clinical trial phases II-IV, post-marketing safety requirements, ICH GCP, GVP, and global PV regulations.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and team collaboration tools.
Excellent communication, organizational, and interpersonal skills.
Highly detail-oriented with the ability to manage multiple tasks and meet deadlines independently.
Work with a global team supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products.
Gain exposure to innovative pharmacovigilance processes and safety databases.
Opportunity for career growth, technical training, and professional development.
Be part of an inclusive culture that values diversity, collaboration, and innovation.
Apply now on ThePharmaDaily.com to advance your career as a Pharmacovigilance Specialist with QC expertise in a leading global biopharmaceutical organization.
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